Oral composition and method for stress reduction associated with smoking cessation

ABSTRACT

A confectionary composition is used in a method of reducing stress and the urge to smoke in abstaining tobacco users. The confectionary composition includes at least one of a sugar or a sugar alcohol and an effective amount of stress-reducing flavoring agent. Where the confectionary composition is a chewing gum, the composition includes a water soluble bulk portion and a water insoluble base portion. The stress-reducing flavoring agent can be one or more of peppermint flavor, vanilla flavor, or peach flavor. The stress-reducing flavoring agent reduces an abstaining tobacco user&#39;s urge to smoke and can reduce the level of salivary Cortisol in the abstaining tobacco user. The method reduces stress in tobacco users who must temporarily abstain from tobacco use and can reduce consumption of tobacco by tobacco users by increasing the interval between consumption events.

RELATED APPLICATION DATA

This application claims priority to U.S. Provisional Patent Applicationhaving Ser. No. 60/722,307, filed Sep. 30, 2005.

TECHNICAL FIELD

The invention relates generally to aids for treating tobacco or nicotinehabits and, more particularly, to oral compositions, such as chewing gumand confectionary compounds, formulated to relieve psychological andphysiological stress associated with smoking cessation.

BACKGROUND

There are about 1.1 billion tobacco smokers worldwide. In the U.S.,about 30% of the population smokes cigarettes, of these, about 36-40%are 18-25 years old. Direct and passive exposure to smoking, andparticularly cigarette smoking, is recognized as a substantial healthfactor, and a major risk factor in a variety of diseases, includingcoronary artery disease and a wide range of cancers. It is alsorecognized that nicotine, a constituent of tobacco, is highly addictive,making decreasing or ceasing to smoke tobacco-related products verydifficult for a significant percentage of tobacco users. As governmentsworldwide increase restrictions on tobacco use in public, there is aneed for methods to assist smokers, and especially young adults, withthe stress of smoking cessation. Many products now in use to reduce theurge to smoke may also directly or indirectly lower stress levelsassociated with smoking cessation.

At present there are several consumer products that attempt to helppeople overcome their addiction to nicotine found in all tobacco relatedproducts. One type of product includes a transdermal patch, which allowsthe person's body to slowly absorb a prescribed amount of nicotine overa given period. Little by little the dosage of nicotine in the patchesis decreased until the person is no longer addicted. Once the physicaladdiction to nicotine is overcome, the person can more easily fight thepsychological stress associated with smoking cessation.

Another type of product is sold in the form of a chewing gum containingnicotine. Thus, whenever a smoker has the urge to smoke, the smoker willchew the gum instead. However, the smoker still has to restrict the useof the gum in a manner that will eventually overcome the addiction.

There are substantial limitations and drawbacks to the various methodsof nicotine-replacement therapy in current use. Orally ingestedmaterials containing nicotine have a bad taste, may lead to mouthulcers, heartburn and other adverse consequences, and are highlydependent of the user following a specific regime. Other forms of oraladministration can result in nausea, unpredictable nicotine blood levelsand the like. Patches, including transdermal patches, and other topicalapplications of nicotine can cause skin irritation, and patchescontaining nicotine are known to cause pruritus.

Devices and methods involving nicotine therapy all necessarily depend onthe use of nicotine, the substance causing addiction, to controlnicotine craving or desire. This approach is thus susceptible to abuse,and users are known to become addicted to the use of gum, patches or thelike, and not to decrease nicotine intake as instructed. In addition,users are known to concurrently use both tobaccos, as in cigarettes, andnicotine therapy aids, such as gum or patches, thereby increasing thetotal intake of nicotine. Further, in such instances acute adversemedical consequences may result, including increased heart rate,increased blood pressure and other conditions associated with nicotineadministration. Accordingly, the use of nicotine therapy may actuallyincrease the stress associated with smoking cessation.

There are certain herbal preparations that are known to have been usedas smoking materials, including use in non-tobacco cigarettes. Forexample, nicotine-free herbal compositions, have been used either as asubstitute for or in combination with tobacco. This smoking compositionmay include Laurus nobilis and Nelumbo garetin. Also, herbs such asPlantago major, Piper methysticum, and Hypericum perforatum have beenused in herbal preparations for aid in cessation of tobacco.

Several non-nicotine chewing gum and confectionary smoking cessationaids have been developed. For example, citrus leaf powder, oat extract,and tea extracts have been used in an anti-smoking chewing gum. Othernon-nicotine confections have been formulated containing sugarsubstitutes. For example, sugar alcohols, maltitol and lactitol, andmenthol or mint flavor have been used in smoking control confections.

BRIEF SUMMARY

In one aspect of the invention, a confectionary composition isformulated to reduce stress and the urge to smoke in abstaining tobaccousers. The composition includes at least one of a sugar or a sugaralcohol and an effective amount of a stress-reducing flavoring agentsufficient to substantially reduce the urge to consume tobacco products.

In another aspect of the invention, a chewing gum composition isformulated to reduce stress and the urge to smoke in abstaining tobaccousers. The composition includes a water soluble bulk portion, a waterinsoluble base portion, and at least one stress-reducing flavoring agentsufficient to substantially reduce the urge to smoke.

In yet another aspect of the invention, a method of reducing the urge tosmoke in abstaining tobacco users includes orally administering aconfectionary composition having an amount of stress-reducing flavoringagent effective to substantially reduce the urge to smoke during periodsof smoking abstinence.

In a further aspect of the invention, a method of reducing stress intobacco users who must temporarily abstain from tobacco use includesorally administering a confectionary composition having an amount ofstress-reducing flavoring agent effective to substantially reduce theurge to smoke during periods of smoking abstinence.

In a still further aspect of the invention, a method of reducingconsumption of tobacco by a tobacco user by increasing the intervalbetween consumption events comprising orally administering aconfectionary composition having an amount of stress-reducing flavoringagent effective to substantially reduce the urge to smoke during periodsof smoking abstinence.

The stress-reducing flavoring agent can be one or more of peppermintflavor, vanilla flavor, or fruit flavors, such as peach flavor.

DETAILED DESCRIPTION

The present invention will now be further described. In the followingpassages, different aspects of the invention are defined in more detail.Each aspect so defined may be combined with any other aspect or aspectsunless clearly indicated to the contrary. In particular, any featureindicated as being preferred or advantageous may be combined with anyother feature or features indicated as being preferred or advantageous.

Confectionary compositions can be used as vehicles for deliveringcomponents to the oral cavity which provide benefits such as breathfreshening and antibactericidal properties. Such systems have theadvantage of providing a consumer with a convenient and inexpensivemethod for maintaining oral health and fresh breath throughout thecourse of the day. Chewing gums and confections such as hard and softcandies also provide the user with certain psychological benefits. Theaction of chewing a gum or sucking on a candy can provide a form ofrelaxation and provide relief of stress and tension in the body.

The cessation of smoking or other forms of tobacco use in tobacco usersis usually accompanied by increased stress levels. The human stresshormone Cortisol is secreted in response to stressful or threateningsituations, such as during periods when a person has the urge to smoke,but cannot because of either environmental restrictions or attempting tobreak the smoking habit. Saliva Cortisol is released in the oral cavityduring times of mental stress or increased body tension. (J. Smyth, etal. “Stressors And Mood Measured On A Momentary Basis Are AssociatedWith Salivary Cortisol Secretion” Psychoneuroendocrinology 1998;23:353-370).

In accordance with an embodiment of the invention, an oral deliveryvehicle, preferably a confectionary product such as a chewing gum or thelike, containing an effective amount of a stress-reducing flavoringagent, is masticated by an abstaining tobacco user. Suitableconfectionary products include tablets, lozenges, hard and soft candies,pressed mints, and the like. The term “masticated” as used hereinincludes operations by which a chewing gum or candy is partially orwholly consumed while it is being held in the mouth, such as by chewing,sucking, or dissolving. Holding the product in the mouth for longerperiods of time is expected to be associated with greater levels ofstress reduction in an abstaining tobacco user.

The present invention provides a confectionary that reduces the anxietyin tobacco users when they cannot smoke. For example, during travel oncommercial airlines, while at meetings, while in non-smokingrestaurants, and the like. These are situations in which tobacco usersmust temporarily abstain from tobacco use. Accordingly, the presentinvention contemplates a method in which a confection containing astress-reducing flavoring agent is used to relieve stress in tobaccousers who must temporarily abstain from tobacco use.

The present invention also provides a confectionary that, when used,effectively increases the time period between tobacco use episodes byreducing the urge to smoke or otherwise use or consume tobacco products.By relieving the stress associated with abstaining from tobacco use, theoverall consumption of tobacco products can be reduced in individualsdesiring to permanently abstain from tobacco use. In this aspect, theinvention provides a method of assisting tobacco users in overcoming atobacco use habit.

The present invention incorporates flavoring agents in a confectionarycomposition that have been discovered to reduce stress generally, andstress related to tobacco abstinence as well as the urge to smoke. Inaccordance with one embodiment of the invention, an oral compositionincludes an effective amount of a flavoring agent such as peppermint orvanilla or both. In other embodiments, an oral composition includes aneffective amount of a fruit flavoring agent, such as peach. Theseflavoring agents have been found effective in reducing the urge to smokein both men and women over an extended period after smoking cessation.In particular, chewing gums containing peppermint or vanilla flavorswere found to reduce saliva Cortisol levels in test subjects in athree-day trial following cessation of cigarette smoking.

Studies conducted to determine the effects of peppermint and vanillaflavored chewing gums have shown an alleviation of withdrawal symptomsand a reduction in the urge to smoke in cigarette smokers. In adouble-blind, randomized cross-over study, the withdrawal symptoms, urgeto smoke, and salivary Cortisol levers were measured in 10 subjects overa three-day trial following cessation of smoking. In the study, thesalivary corisol levels in 5 women and 5 men were measured at severalintervals on the third day of the abstinence test period. Both the urgeto smoke and the overall withdrawal symptoms were measured on the thirdday of the abstinence.

In the study, the subjects had their last cigarette before going to bedon Sunday. They did not smoke on Monday, the first day of abstinence,but answered questions relating to symptoms and urge to smoke at about10 am. This was designated as zero hour. The “48 hour” tests were run atabout 10:00 am on Wednesday, the third day of abstinence. Saliva sampleswere taken throughout Wednesday. Thus, by the time the last salivasample was taken on Wednesday night, the subjects had gone 72 hourssince their last cigarette. Abstinence was enforced by testing forcarbon monoxide in the breath—a clear indicator of cigarette smoking.

Table 1 below shows scale values relating to the urge to smoke for theoverall study as a group, and for the women and the men within thegroup. TABLE 1 Urge To Smoke At A 48 Hour Interval After Cessation OfSmoking (self-reported scale values) Total Women Men Peppermint Gum 73.983.6 64.2 Vanilla Gum 64.3 61.2 67.4 No Gum 85.1 88.8 81.4

The values shown in Table 1 are Visual Analog Scale Values in which thesubjects indicated on a 100 mm line scale the degree of their subjectiveurge to smoke. The scale values ranged from 0 (no urge to smoke) to 100(maximum urge to smoke).

Overall, both peppermint and vanilla flavored chewing gums substantiallyreduced the urge to smoke in comparison with no chewing gum. Further,the study showed that, overall, vanilla flavored chewing gum had a morepronounced effect on the urge to smoke than peppermint flavored chewinggum. The vanilla flavored chewing gum reduced the urge to smoke by about24% compared with no chewing gum.

Within the group, vanilla flavored chewing gum reduced the urge to smokein the female subjects by about 31%, while the peppermint chewing gumhad a much less pronounced reduction. In men, the peppermint flavoredchewing gum reduced the urge to smoke by about 21%, while the vanillaflavored chewing gum had a slightly less effect on the urge to smoke.

The total withdrawal systems in the test subjects are shown in Table 2below. TABLE 2 Total Withdrawal Symptoms At A 48 Hour Interval AfterCessation Of Smoking (average scale values of self-reported symptomseverity) Total Women Men Peppermint Gum 11.6 12.8 10.4 Vanilla Gum 13.514.2 12.8 No Gum 16.5 18.6 14.4

The values listed in Table 2 are the average of the subject'sself-reported severity of eleven smoking cessation-related symptoms. Thevalues for each symptom are provided on a four-point scale. The valuesfor each symptom range from 0 (not present) to 3 (severe). Thus, in theaverages listed above in Table 2, the maximum possible score when alleleven symptoms are at their highest level for any one subject is 33.

In the overall study group, both peppermint flavored chewing gum andvanilla flavored chewing gum substantially reduced the total withdrawalsymptoms. The peppermint and vanilla flavored chewing gums reduced thetotal withdrawal symptoms by 30% and 18%, respectively. In the femalesubjects, peppermint flavored chewing gum reduced the total withdrawalsymptoms by about 30%, while the vanilla flavored chewing gum reducedthe total withdrawal symptoms by about 24%. In the male subjects, thepeppermint flavored chewing gum reduced the total withdrawal symptoms byabout 28%, while the vanilla flavored chewing gum showed much lesseffect.

During the third day of abstinence, the saliva samples were taken at sixintervals throughout the day: upon wakening (A), 45 minutes later(A+45), at noon (12), at 6:00 pm (6), between 8:00 and 9:00 pm (8-9),and at bed time (B). Cortisol levels are known to peak shortly afterrising in the morning and then decline throughout the day. Using thepeak Cortisol level as a baseline, the reduction in saliva Cortisollevels was determined for the control and experimental treatments.

Table 3 shows the relative saliva Cortisol levels taken from the testsubjects at the various time intervals on the third day followingcessation of smoking. The values shown in the table are nanomoles ofCortisol per milliliter of saliva. TABLE 3 Saliva Cortisol Levels On TheThird Day After Cessation Of Smoking (nanomoles/ml) A A + 45 12 6 8-9 BPeppermint Gum 0.53 0.50 0.32 0.12 0.18 0.20 Vanilla Gum 0.40 0.59 0.250.10 0.09 0.12 No Gum 0.34 0.42 0.29 0.22 0.20 0.11

The results are shown for subjects that were allowed to chew peppermintflavored chewing gum, vanilla flavored chewing gum, and no chewing gum.As shown above in Table 3, peak salivary Cortisol levels were measuredin the test subjects at the time of awakening (A) and shortly afterarising (A+45), then declined over the remainder of the day. Thesubjects chewing either the peppermint flavored chewing gum or thevanilla flavored chewing gum showed greater reductions from peak levelsthan did the subjects who chewed no gum. This indicates that theexperimental gums were effective in substantially reducing stress insmokers on the third day of abstinence.

As illustrated in the foregoing description, the stress associated withabstaining from the use of tobacco products can be substantially reducedby consuming a confectionary composition having a stress-reducingflavoring agent.

The following examples illustrate various embodiments of the inventionfor oral compositions including stress-reducing flavoring agents.

Chewing Gum

Pursuant to the present invention, a flavor such as peppermint, vanilla,peach flavor or other stress-reducing flavoring agents can be used toformulate a chewing gum. In this regard, the present invention alsoprovides a chewing gum comprising a water insoluble base portion, awater soluble base portion, and a stress-relieving flavoring agent. Thewater soluble portion dissipates with a portion of the flavor over aperiod of time during chewing. The gum base portion is retained in themouth throughout the chew. The chewing gum may be any of a variety ofdifferent chewing gums, including low or high moisture, sugar orsugarless, wax-containing or wax-free, low calorie and/or a chewing gumthat includes dental health agents.

The insoluble gum base generally comprises elastomers, resins, fats andoils, softeners, and inorganic fillers. The gum base may or may notinclude wax. The insoluble gum base can constitute about 5 to about 95percent, by weight, of the chewing gum, more commonly, the gum basecomprises about 10 to about 50 percent of the gum, and in some preferredembodiments, about 20 to about 35 percent, by weight, of the chewinggum.

In one formulation, the chewing gum base contains about 20 to about 60weight percent synthetic elastomer, about 0 to about 30 weight percentnatural elastomer, about 5 to about 55 weight percent elastomerplasticizer, about 4 to about 35 weight percent filler, about 5 to about35 weight percent softener, and optional minor amounts (about onepercent or less) of miscellaneous ingredients such as colorants,antioxidants, and the like.

Synthetic elastomers may include, but are not limited to,polyisobutylene with a GPC weight average molecular weight of about10,000 to about 95,000, isobutylene-isoprene copolymer (butylelastomer), styrene-butadiene copolymers having styrene-butadiene ratiosof about 1:3 to about 3:1, polyvinyl acetate having a GPC weight averagemolecular weight of about 2,000 to about 90,000, polyisoprene,polyethylene, vinyl acetate-vinyl laurate copolymer having vinyl lauratecontent of about 5 to about 50 percent by weight of the copolymer, andcombinations thereof.

Preferred ranges are, for polyisobutylene, about 50,000 to about 80,000GPC weight average molecular weight, for styrene-butadiene, 1:1 to 1:3bound styrene-butadiene, for polyvinyl acetate, 10,000 to 65,000 GPCweight average molecular weight with the higher molecular weightpolyvinyl acetates typically used in bubble gum base, and for vinylacetate-vinyl laurate, vinyl laurate content of about 10 to about 45percent.

Natural elastomers may include natural rubber such as smoked or liquidlatex and guayule as well as natural gums such as jelutong, lechi caspi,perillo, sorva, massaranduba balata, massaranduba chocolate, nispero,rosindinha, chicle, gutta hang kang, and combinations thereof. Thepreferred synthetic elastomer and natural elastomer concentrations varydepending on whether the chewing gum in which the base is used isadhesive or conventional, bubble gum or regular gum, as discussed below.Preferred natural elastomers include jelutong, chicle, sorva andmassaranduba balata.

Elastomer plasticizers may include, but are not limited to, naturalrosin esters such as glycerol esters of partially hydrogenated rosin,glycerol esters polymerized rosin, glycerol esters of partiallydimerized rosin, glycerol esters of rosin, pentaerythritol esters ofpartially hydrogenated rosin, methyl and partially hydrogenated methylesters of rosin, pentaerythritol esters of rosin; synthetics, such asterpene resins derived from alpha-pinene, beta-pinene, and/ord-limonene; and any suitable combinations of the foregoing, thepreferred elastomer plasticizers will also vary depending on thespecific application, and on the type of elastomer which is used.

Fillers/texturizers may include magnesium and calcium carbonate, groundlimestone, silicate types such as magnesium and aluminum silicate, clay,alumina, talc, titanium oxide, mono-, di- and tri-calcium phosphate,cellulose polymers, such as wood, and combinations thereof.

Water insoluble softeners and emulsifiers are typically incorporatedinto the gum base at levels between 5 and 50%. These may include fatssuch as tallow, hydrogenated tallow, hydrogenated and partiallyhydrogenated vegetable oils, cocoa butter; fatty ingredients such asglycerol monostearate and other mono- and diglycerides, glyceroltriacetate, lecithin, acetylated mono- and diglycerides, fatty acids(e.g. stearic, palmitic, oleic and linoleic acids), waxes such asparaffin and microcrystalline waxes and combinations thereof.

Colorants and whiteners may include FD&C-type dyes and lakes, fruit andvegetable extracts, titanium dioxide, and combinations thereof.

The gum base may or may not include wax. An example of a wax-free gumbase is disclosed in U.S. Pat. No. 5,286,500, the disclosure of which isincorporated herein by reference.

In addition to a water insoluble gum base portion, a typical chewing gumcomposition includes a water soluble bulk portion and one or moreflavoring agents. The water soluble portion can include bulk sweeteners,high intensity sweeteners, flavoring agents, softeners, emulsifiers,colors, acidulants, fillers, antioxidants, and other components thatprovide desired attributes.

Bulk sweeteners include both sugar and sugarless components. Bulksweeteners typically constitute about 5 to about 95% by weight of thechewing gum, more typically, about 20 to about 80% by weight, and morecommonly, about 30 to about 60% by weight of the gum.

Sugar sweeteners generally include saccharide-containing componentscommonly known in the chewing gum art, including, but not limited to,sucrose, dextrose, maltose, dextrin, dried invert sugar, fructose,levulose, galactose, corn syrup solids, and the like, alone or incombination.

Sugarless sweeteners include, but are not limited to, sugar alcoholssuch as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates,maltitol, and the like, alone or in combination, and polymeric sucrosereplacers including maltodextrins, polydextrose, and hydrogenated starchhydrolysate (HSH).

High intensity artificial sweeteners can also be used, alone or incombination with the above. Preferred sweeteners include, but are notlimited to sucralose, aspartame, Neotame, salts of acesulfame, such asthe synthetic sweetener3,6-dihydro-6-methyl-1-1,2,3-oxathiazin-4-one-2,2-dioxide, particularlythe potassium substituted sweetener (Acesulfame-K), alitame, saccharinand its salts, cyclamic acid and its salts, glycyrrhizin,dihydrochalcones, thaumatin, monellin, and the like, alone or incombination. In order to provide longer lasting sweetness and flavorperception, it may be desirable to encapsulate or otherwise control therelease of at least a portion of the artificial sweetener. Suchtechniques as wet granulation, wax granulation, spray drying, spraychilling, fluid bed coating, coacervation, and fiber extension may beused to achieve the desired release characteristics.

Usage level of the artificial sweetener will vary greatly and willdepend on such factors as potency of the sweetener, rate of release,desired sweetness of the product, level and type of flavor used and costconsiderations. Thus, the active level of artificial sweetener may varyfrom about 0.02 to about 8%. When carriers used for encapsulation areincluded, the usage level of the encapsulated sweetener will beproportionately higher.

Encapsulated sweeteners can also be incorporated into the gumformulation. The encapsulation techniques that can be used can givevarying degrees of coating from partial to full coating depending on thecoating composition used in the process. Also the coating compositionsmay be susceptible to water permeating to various degrees. Generally,compositions that have high organic solubility, good film formingproperties, and low water solubility, provide a better encapsulation ofaspartame. Such compositions include acrylic polymers and copolymers,carboxyvinyl polymers, polyamides, polystyrene, polyvinyl acetate,polyvinyl acetate phthalate, polyvinyl pyrrolidone, and waxes.

Although all of the above materials are possible for the encapsulationof aspartame, only food grade materials should be used. Two standardfood grade coating materials that are good formers, but not watersoluble, are shellac and Zein. Others which are more water soluble, butalso good film formers, are materials such as agar, alginates, a widerange of cellulose derivative like ethyl cellulose andhydroxpropylmethyl cellulose, dextrin, gelatin and modified starches.Other encapsulants like acacia or maltodextrin can also be used toencapsulate the aspartame.

Generally, the higher the level of coating and the lower the amount ofaspartame, the higher the stability of aspartame. To obtain the desiredencapsulation, the encapsulant should be preferably at least about 20%of the coated product. More preferably, the encapsulant should be atleast about 30% of the coated product, and most preferably should be atleast about 40% of the coated product. Depending on the coatingmaterial, a higher or lower amount of coating material may be needed toprovide the desired encapsulation.

Another method of partial encapsulation is agglomeration with anagglomerating agent, which partially coats aspartame. This methodincludes the step of mixing the aspartame and agglomerating agent with asmall amount of water or solvent. The mixture is prepared in such a wayas to have individual wet particles in contact with each other so apartial coating can be applied. After the water or solvent is removed,the mixture is ground and used as a powdered coated encapsulatedaspartame.

Materials that can be used as the agglomerating agent are the same asthose used in the encapsulation previously mentioned. However, since thecoating is only a partial encapsulation, some agglomeration agents aremore effective than others. Some of the better agglomerating agents areorganic polymers such as acrylic polymer and copolymers, polyvinylacetate, polyvinyl pyrrolidone, waxes, shellac and Zein. Otheragglomerating agents may not be as effective as are the polymers, waxes,shellac and Zein. These other agglomerating agents include, but are notlimited to, agar, alginates, a wide range of cellulose derivatives,dextrin, gelatin, modified starches, and vegetable gums such as guargums, locust bean gum, and carrageenan.

Even though the agglomerated aspartame is only partially coated, whenthe quantity of coating is increased compared to the quantity ofaspartame, improved aspartame stability is obtained. The level ofcoating used in the agglomerated product should be at about 5%.Preferably the coating level should be at least about 15%, and morepreferably about 20%.

Aspartame may be coated in a two-step process or multiple step process.Aspartame may be encapsulated with any of the materials previouslydescribed and then the encapsulated material can be agglomerated aspreviously described to obtain an encapsulated/agglomerated product thatcould be used in chewing gum to improve stability.

Combinations of sugar and/or sugarless sweeteners may be used in chewinggum. Additionally, the softener may also provide additional sweetnesssuch as with aqueous sugar or alditol solutions.

If a low calorie gum is desired, a low caloric bulking agent can beused. Examples of low caloric bulking agents include: polydextrose;Raftilose, Raftilin; Fructooligosaccharides (NutraFlora); Palatinoseoligosaccharide; Guar Gum Hydrolysate (Sun Fiber); or indigestibledextrin (Fibersol). However, other low calorie bulking agents can beused.

Softeners are added to the chewing gum in order to optimize thechewability and mouth feel of the gum. Softeners, also known in the artas plasticizers or plasticizing agents, generally constitute betweenabout 0.5% to about 15% of the chewing gum. These include glycerin,propylene glycol and aqueous sweetener solutions such as thosecontaining sorbitol. Hydrogenated starch hydrolysate and corn or otherstarch hydrolysate syrups (sometimes called glucose syrups) andcombinations thereof are particularly preferred as they also function asbinders to improve the flexibility and other physical properties of thegum.

In addition to the stress-reducing flavoring agents described above, avariety of additional flavoring agents can be used. The flavor can beused in amounts of approximately about 0.1 to about 10 weight percent ofthe gum, and preferably, about 0.3 to 2%. Flavoring agents may includeessential oils, synthetic flavors or mixtures thereof including, but notlimited to, oils derived from plants and fruits. In addition topeppermint oil, vanilla, and peach, other mint oils including spearmintoil, can be added. Artificial flavoring agents and components may alsobe used. Natural and artificial flavoring agents may be combined in anysensorially acceptable fashion.

The stress-reducing flavoring agent can be in the form of a spray-driedflavor. Spray-drying of the flavor oils, such as peppermint oil, can beaccomplished by conventional spray-drying techniques whereby a carriersolution or mixture containing the flavor oil is fed through a pressurenozzle and atomized. Generally, the spray-dried flavor is present in thecarrier mixture in amounts of about 15 to about 20% by weight of thetotal carrier and flavor. In the case of spray-dried mint flavors whichare to be used in sugar-containing chewing gum compositions, the carriersolution can be a sucrose solution. In sugarless formulations, thecarrier solution can be an aqueous gum arabic solution.

The oral composition of the invention can also contain cooling agentsand cooling flavors, such as those disclosed in U.S. Pat. No. 6,627,233,the disclosure of which is incorporated by reference herein. Coolingagents and flavors are used in chewing gum to improve the “cool”sensation perceived upon chewing the gum and to extend the duration ofthe “cool” sensation. In chewing gums, adding a cooling agent providesthe chewing gum with an unexpected, high-flavor impact. This isparticularly valuable for sugarless chewing gum where the harsh notes ofan added flavor are not masked by sugar. Several different known coolingagents can be used including menthyl succinate; acyclic carboxamide;menthyl lactate; 3-1-menthoxypropane-1,2-diol; N-substituted p-menthanecarboxamide; menthone glycerol ketals and mixtures thereof.

In an additional aspect, a cooling agent or combinations of coolingagents can be treated to have a modified-release. The controlled releasecombination of physiological cooling agents is obtained by modifying thecooling agents by encapsulation, partial encapsulation or partialcoating, entrapment or absorption with water-soluble materials orwater-insoluble materials. The procedures for modifying thephysiological cooling agents include spray drying, spray chilling,fluid-bed coating, coacervation, extrusion, and other agglomerating andstandard encapsulating techniques. The cooling agents may also beabsorbed onto an inert or water-insoluble material. The cooling agentsmay be modified in a multiple step process comprising any of theprocesses noted.

In general, the chewing gum is manufactured by sequentially adding thevarious chewing gum ingredients to a commercially available mixer knownin the art. After the ingredients have been thoroughly mixed, the gummass is discharged from the mixer and shaped into the desired form, suchas rolling into sheets and cutting into sticks or tabs, extruding intochunks or casting into pellets, which are then coated or panned.

Generally, the ingredients are mixed by first melting the gum base andadding it to the running mixer. The base may also be melted in the mixeritself. Color or emulsifiers may also be added at this time. Thesoftener may also be added at this time, along with syrup and a portionof the bulking agent. Further parts of the bulking agent are added tothe mixer. Flavoring agents, such as the stress-reducing flavoring agentdescribed above are added with the final portion of the bulking agent.Other optional ingredients are added to the batch in a typical fashion,well known to those of ordinary skill in the art.

The entire mixing procedure typically takes from five to fifteenminutes, but longer mixing times may sometimes be required. Thoseskilled in the art will recognize that many variations of the abovedescribed procedure may be followed.

After the ingredients are mixed, the gum mass is either sheeted orformed into pellets or balls. Pellet or ball gum is prepared asconventional chewing gum but formed into pellets that are pillow shaped,or into balls.

If a coated chewing gum is desired, the pellets/balls can be used ascores for a coated chewing gum product having a core. The cores can besugar or polyol coated or panned by conventional panning techniques tomake a coated pellet gum. The weight of the coating may be about 20% toabout 50% of the weight of the finished product, but may be as much as75% of the total gum product.

Conventional panning procedures generally coat with sucrose, but recentadvances in panning have allowed use of other carbohydrate materials tobe used in place of sucrose. Some of these coating materials include,but are not limited to, sugars such as dextrose, maltose, isomaltulose,and tagatose, or sugarless bulk sweeteners such as xylitol, sorbitol,lactitol, hydrogenated isomaltulose, erythritol, maltitol, and other newpolyols (also referred to as alditols) or combinations thereof. Apreferred coating comprises about 30% to about 75% maltitol. Thesematerials may be blended with panning modifiers including, but notlimited to, gum arabic, gum talha, maltodextrins, corn syrup, gelatin,cellulose type materials like carboxymethyl cellulose or hydroxymethylcellulose, starch and modified starches, vegetables gums like alginates,locust bean gum, guar gum, and gum tragacanth. Antistick agents may alsobe added as panning modifiers, which allow the use of a variety ofcarbohydrates and sugar alcohols. Flavors, such as the stress-reducingflavoring agents described above, may also be added with the sugar orsugarless coating to yield unique product characteristics.

Table 4 below provides two exemplary chewing gum formulations inaccordance with aspects of the invention. TABLE 4 Chewing GumComposition Vanilla Flavored Peppermint Flavored Ingredient Gum Gum GumBase 25.90 25.90 Alditol/Glycerin Syrup 37.90 37.90 Sorbitol 33.54 31.91Encapsulated Acesulfame K 0.75 0.75 Encapsulated Aspartame 0.11 0.11Acesulfame K 0.05 0.05 Lecithin 0.10 0.10 Salt Solution (10%) 0.05 0.05Water 0.10 0.10 Vanilla Flavor 1.50 — Peppermint Flavor — 1.95 SprayDried Peppermint — 0.10 Spray Dried Cooling Agent — 0.08 Cocoa GlycerinDispersion — 1.00 Total 100.00 100.00

The Alditol/Glycerin Syrup listed above is a blend of sorbitol solution,hydrogenated starch hydrolysate syrup, and glycerin co-evaporated toabout 3% moisture. The composition of the Alditol/Glycerin Syrupcomposition is given below in Table 5. TABLE 5 Alditol/Glycerin SyrupComposition Glycerin 39.00 Mannitol 1.50 HSH solids 5.50 Sorbitol 51.00Water 3.00 Total 100.00

Candy

In another aspect of the invention, confectionery compositions orproducts containing stress-reducing flavoring agents can include, forexample, hard candies, chewy candies, coated chewy center candies, andtabletted candies. By way of example, the hard candy is primarilycomprised of corn syrup and sugar, and derives its name from the factthat it contains only 1% and 4% moisture. In appearance, these types ofcandies are solid, but they are actually supercooled liquids, which arefar below their melting points. There are different types of hardcandies. Glass types are usually clear or made opaque with dyes. Grainedtypes of hard candies are always opaque.

Another aspect of the present invention contemplates the incorporationof the stress reducing flavoring agents into solid oral carriers such asslow dissolving tablets or lozenges manufactured by conventionaltechniques. The solid carrier is sugar or a water soluble polyhydricalcohol (polyol) such as mannitol, xylitol, sorbitol, maltitol, ahydrogenated starch hydrolysate (“Lycasin”), hydrogenated glucose,hydrogenated disaccharides, and/or hydrogenated polysaccharides, as themajor ingredient, in an amount of about 85-98% by weight of the totalcarrier. Solid salts such as sodium bicarbonate, sodium chloride,potassium bicarbonate or potassium chloride may totally or partiallyreplace the polyol carrier.

Tableting lubricants, in minor amounts of about 0.1 to 5% by weight, maybe incorporated into the tablet or lozenge formulation to facilitate thepreparation of both the tablets and the lozenges. Suitable lubricantsinclude vegetable oil such as coconut oil, magnesium stearate, aluminumstearate, talc, starch and Carbowax.

Lozenge formulations may contain about 2% hydrocolloid as a barrieragent to provide a shiny surface as opposed to a tablet which has asmooth finish. The lozenge or tablet may optionally be coated with acoating material such as waxes, shellacs, carboxymethyl cellulose,polyethylene/maleic anhydride copolymer or Kappa-carrageenan, to furtherincrease the time it takes the tablet or lozenge to dissolve in themouth. The coated tablet or lozenge should be slowly dissolving,providing a sustained release rate of the active ingredients over theperiod of about 3 to about 15 minutes.

The stress-reducing flavoring agents of the present invention areincorporated into a lozenge or tablet by conventional mixing andtableting techniques known in this field.

The present embodiment of the invention further contemplates theoptional inclusion of a sweetener, flavorant, or colorant component intothe tablets or lozenges containing stress-reducing flavoring agents.

The sweetener component comprises any one or more sweeteners known inthe art, including both natural and artificial sweeteners. The sweetenermay be chosen from a wide range of materials, including water-solublesweeteners, water-soluble artificial sweeteners, dipeptide basedsweeteners, and mixtures thereof. Thus, sweeteners may be chosen fromthe following non-limiting list, which includes sugars such as sucrose,glucose, corn syrup, dextrose, invert sugar, fructose and mixturesthereof; saccharine and its various salts such as the sodium or calciumsalt; cyclamic acid and its various salts such as the sodium salt; freeaspartame; dihydrochalcone sweetening compounds; glycyrrhizin;stevioside; monellin; thaumatin; sucralose; isomaltitol; neosugar;lactitol; polydextrose; tagatose; maltitol; and sugar alcohols such assorbitol, sorbitol syrup, mannitol, xylitol, and the like. Alsocontemplated as a sweetener is the nonfermentable sugar substitutehydrogenated starch hydrolysate (also known as Lycasin). Alsocontemplated is the synthetic sweetener3,6-dihydro-6-methyl-1-1,2,3-oxathiazin-4-one-2,2-dioxide, particularlypotassium (Acesulfame-K), sodium and calcium salts thereof. Sorbitol isthe preferred sweetening and bulking agent. The amount of sweetenerincluded is an amount effective to provide the desired degree ofsweetness and bulk, generally 0.001 to 70 weight % of the tablet orlozenge.

High intensity artificial sweeteners can also be used, alone or incombination, with the above. Preferred sweeteners include, but are notlimited to, sucralose, aspartame, APM derivatives such as neotame, saltsof acesulfame, altitame, saccharin and its salts, cyclamic acid and itssalts, glycyrrhizinate, dihydrochalcones, thaumatin, monellin, and thelike, alone or in combination. In order to provide longer lastingsweetness and flavor perception, it may be desirable to encapsulate orotherwise control the release of at least a portion of the artificialsweetener. Such techniques as wet granulation, wax granulation, spraydrying, spray chilling, fluid bed coating, coacervation, and fiberextension may be used to achieve the desired release characteristics.

In addition to the stress-reducing flavoring agents, additionalflavorants may be included. Suitable additional flavorants includenatural and artificial flavors, such as menthol, oil of spearmint, oilof cinnamon, oil of wintergreen (methyl salicylate), and various fruitflavors, including but not limited to lemon oil, orange oil, grapeflavor, lime oil, grapefruit oil, apple, apricot essence, andcombinations thereof. As described above, particularly preferred flavorsare stress-reducing flavoring agents, such as peppermint, vanilla, andpeach. The flavorings are generally utilized in amounts that will varydepending upon the individual flavor, and may, for example, range inamounts of about 0.5% to about 3% by weight of the tablet or lozenge.

Colorants can be present in the tablets or lozenges of the presentinvention. Examples include pigments such as titanium dioxide, naturalfood colorants such as beta carotenes, betanin, turmeric, and other dyessuitable for food, drug and cosmetic applications known as F.D. & C.dyes, and the like. The materials may be incorporated in amounts of upto about 1% by weight, preferably up to about 6% by weight of the tabletor lozenge.

The stress-reducing flavoring agents may be incorporated into anotherwise conventional pressed tablet formulation. The pressed tabletinto which the stress-reducing flavoring agents are incorporated may beprepared by wet granulation, dry granulation, and direct compressionmethods. These methods involve conventional procedures well known to theordinary skilled artisan. In general, wet granulation involves mixingmilled powders, preparing a wet mass by blending the milled powders witha binder solution, coarse screening the wet mass and drying the moistgranules, screening the granules through a 14 to 20 mesh screen, mixingthe screened granules with lubricants and disintegrate agents andfinally tablet compressing the mass. In contrast, dry granulationgenerally involves milling of powders, compression into large hardtablets to make slugs, screening of slugs, mixing with lubricants anddisintegrating agents and finally tablet compression. In the directcompression method, the milled ingredients are mixed and then merelytabletted by compression.

The pressed tablet ingredients used in the invention are selected fromthose materials routinely used. Such ingredients primarily includesweeteners, lubricants, and optional coloring agents, binders andfillers.

Sweetening agents may be selected from a wide range of materials such aswater-soluble sweetening agents, water-soluble artificial sweeteners,and dipeptide based sweeteners, including mixtures thereof. Withoutbeing limited to particular sweeteners, representative illustrationsencompass: 1) Water-soluble sweetening agents such as monosaccharides,disaccharides and polysaccharides such as xylose, ribose, glucose,mannose, galactose, lactose, fructose, dextrose, sucrose, sugar,maltose, partially hydrolyzed starch, or corn syrup solids and sugaralcohols such as sorbitol, xylitol, mannitol and mixtures thereof; 2)Water-soluble artificial sweeteners such as the soluble saccharin salts,i.e. sodium or calcium saccharin salts, cyclamate salts and the like,and the free acid form of saccharin; 3) Dipeptide based sweetenersinclude L-aspartyl-L-phenylalanine methyl ester and related compounds.

In general, the amount of sweetener will vary with the desired amount ofsweetener selected. This amount will normally be about 0.001% to about98% by weight when using an easily extractable sweetener. Thewater-soluble sweeteners are preferably used in amounts of about 75% toabout 98% by weight, and most preferably about 80% to about 95% byweight of the final tablet composition. In contrast, the artificialsweeteners are used in amounts of about 0.01% to about 5.0% and mostpreferably about 0.05% to about 0.25% by weight of the final tabletcomposition. These amounts are necessary to achieve a desired level ofsweetness independent from the flavor level achieved from the flavoroil.

Lubricants are used in the tablet formulations in order to ease theejection of the tablet from the die, to prevent sticking of the tabletsto the punches and to limit wear on dies and punches. Tabletinglubricants may be selected from a wide range of materials such asmagnesium stearate, calcium stearate, zinc stearate, hydrogenatedvegetable oils, talc, light mineral oil, sodium benzoate, sodium laurylsulfate, magnesium lauryl sulfate and mixtures thereof. Magnesiumstearate is the preferred lubricant in view of its ready availabilityand efficient lubrication properties.

The lubricants should be in as fine a state of subdivision as possiblesince the smaller the particle size the greater the efficiency in thegranulation. Preferred sizes are those that pass through an 80 or 100mesh screen and most preferred through a 200 mesh screen before use. Theamount of lubricant will vary broadly and is preferably from about 0.1%to about 5% by weight of the total composition.

Colorants should be selected from materials that are unaffected byhigher temperatures and are considered optional ingredients in thetablet formulations. Such materials when used are employed in amounts of0 to about 0.03% by weight of the total formulation.

Binders that are used when a wet granulation process is employed includestarch, pregelatinized starch, gelatin, free polyvinylpyrrolidone,methylcellulose, sodium carboxymethylcellulose, polyvinylalcohols and soforth. Binders when used can be employed in amounts up to about 25% andpreferably about 5 to about 15% by weight. Conventional fillers may alsobe present such as calcium sulfate, dicalcium phosphate, tricalciumphosphate, starch, microcrystalline cellulose and so forth in amounts upto about 50% by weight with preferred amounts from about 5 to 20% byweight of the final formulation.

The pressed tablet formulations can be prepared by conventional meansusing standard techniques and equipment known to those skilled in theart. In one method, stress-reducing flavoring agents are blended withthe tablet formulation ingredients. Once incorporated, mixing iscontinued until a uniform mixture is obtained and thereafter the mixtureis formed into suitable shapes by subjecting the formulation to atableting operation. Compression pressures on the order up to 65megapascals (approximately 12 tons per square inch) are normallyemployed.

In the event that the oral composition is in the form of a lozenge or apressed tablet, a barrier agent is usually present, preferably in aconcentration of up to about 2 weight %. The barrier agent provides ashiny surface as opposed to a tablet which, although having a smoothfinish, is usually not shiny. In a preferred embodiment, the barrieragent is a hydrocolloid.

Where the oral composition is a lozenge, a tablet, or a pressed tablet,these products may be coated with a coating material. Among the coatingmaterials suitable for use in this application are waxes, shellacs,carboxymethyl cellulose, ethylene-maleic anhydride copolymers andcarragennan. A coating material is used to increase the time it takesfor the tablet or lozenge to dissolve in the mouth. A coated tablet orlozenge is slow dissolving, providing sustained release of the activeingredients over a longer period of time, for example 3 to 15 minutes,or sometimes even longer.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. For example, other comestibles which may beformed from the components discussed above are within the contemplationof the present invention. Such changes and modifications can be madewithout departing from the spirit and scope of the present invention andwithout diminishing its intended advantages. It is therefore intendedthat such changes and modifications are within the scope of the appendedclaims and equivalents thereof.

1. A confectionary composition, formulated to reduce stress and the urgeto smoke in abstaining tobacco users, the composition comprising: (a) atleast one of a sugar or a sugar alcohol; and (b) an effective amount ofa stress-reducing flavoring agent sufficient to substantially reduce theurge to consume tobacco products.
 2. The composition of claim 1 whereinthe stress-reducing flavoring agent comprises peppermint flavor.
 3. Thecomposition of claim 1 wherein the stress-reducing flavoring agentcomprises vanilla flavor.
 4. The composition of claim 1 wherein thestress-reducing flavoring agent comprises a combination of peppermintflavor and vanilla flavor.
 5. The composition of claim 1 wherein thestress-reducing flavoring agent comprises peach flavor.
 6. Thecomposition of claim 1 wherein the composition comprises a chewing gum.7. The composition of claim 1 wherein the composition comprises a hardcandy.
 8. The composition of claim 1 wherein the composition comprises asoft candy.
 9. The composition of claim 1 wherein the compositionfurther comprises an artificial sweetener.
 10. The composition of claim1 wherein the stress-reducing flavoring agent reduces the level ofsalivary Cortisol in the abstaining tobacco users.
 11. A chewing gumcomposition formulated to reduce stress and the urge to smoke inabstaining tobacco users, the composition comprising: (a) a watersoluble bulk portion; (b) a water insoluble base portion; and (c) aneffective amount of at least one stress-reducing flavoring agentsufficient to substantially reduce the urge to smoke.
 12. The chewinggum composition of claim 11 wherein the water soluble bulk portioncomprises one or more sweeteners, high intensity sweeteners, flavoringagents, softeners, emulsifiers, colors, acidulants, fillers, andantioxidants.
 13. The chewing gum composition of claim 11 wherein thewater insoluble base portion comprises one or more of elastomers,resins, fats and oils, softeners, and inorganic fillers.
 14. The chewinggum of claim 11 wherein the stress-reducing flavoring agent comprisespeppermint flavor.
 15. The chewing gum of claim 14 wherein thepeppermint flavor comprises spray dried peppermint flavor.
 16. Thechewing gum of claim 11 wherein the stress-reducing flavoring agentcomprises vanilla flavor.
 17. The chewing gum of claim 11 wherein thestress-reducing flavoring agent comprises a combination of peppermintflavor and vanilla flavor.
 18. The chewing gum of claim 11 wherein thestress-reducing flavoring agent comprises peach flavor.
 19. The chewinggum of claim 11 wherein the water soluble bulk portion comprises a watersoluble polyhydric alcohol and artificial sweeteners.
 20. A coatedchewing gum product comprising the composition of claim
 11. 21. A methodof reducing the urge to smoke in abstaining tobacco users comprisingorally administering a confectionary composition having an amount ofstress-reducing flavoring agent effective to substantially reduce theurge to smoke during periods of smoking abstinence.
 22. The method ofclaim 21 wherein the oral administration of the confectionarycomposition reduces psychological anxiety during periods of smokingabstinence.
 23. The method of claim 21 wherein the oral administrationof the confectionary composition increases the time period betweentobacco use sessions in a habitual tobacco user.
 24. A method ofreducing stress in tobacco users who must temporarily abstain fromtobacco use comprising orally administering a confectionary compositionhaving an amount of stress-reducing flavoring agent effective tosubstantially reduce the urge to smoke during periods of smokingabstinence.
 25. A method of reducing consumption of tobacco by a tobaccouser by increasing the interval between consumption events comprisingorally administering a confectionary composition having an amount ofstress-reducing flavoring agent effective to substantially reduce theurge to smoke during periods of smoking abstinence.